Sr. Director Clinical Operations
Proclinical is currently recruiting for a Senior Director of Study Operations for a leading biotechnology company located remotely. As the Sr. Director, you will be accountable for efficient and effective program management of clinical trial operations - accountable for planning and successful delivery of clinical trials across the platform to time, cost and quality.
- Drive and implement critical initiatives on the program level ensuring success of cross functional team delivery.
- Provide updates, line of sight, risks and timelines to executive team for strategic and investment decision making
- Contribute and approve study related documentation including content necessary for any regulatory body approval. Participate in regulatory interactions as needed
- Clinical contributions to inspection readiness and determination of clinical audit needs. Including identifying and managing CAPAs and other compliance issues
- Accountable for study level risk assessments and mitigation activities and contribute to product platform risk assessments. Evidence of risk-based quality management approach
- To chair and facilitate study meetings with the internal/external teams, investigators, collaborators/alliance partners and any vendors to manage team actions, track study progress, and regularly communicate study progress to executive team
- Identify and retention of talent for continued growth of clinical operations team needs
- Accountable for the overall recruitment plan development and delivery including using external vendors as needed
- Ensuring a control framework is established and maintained to be compliant with all applicable laws and regulations governing the conduct of human subject research
- Oversight on eTMF and study document compliance
- Provide critical analysis and thinking, advice and recommendations on issues associated with the scientific protocol, based on operational aspects to be considered for delivery
Skills and Requirements:
- Training in health/sciences ideally with advanced degree preferred (MPH, MS, PhD) or experience equivalent.
- 10 years experience in working in clinical trial operations (including site operations) with evidence of increasing experience and level of responsibility. Preference to be given to those with 5 years of vaccine/biologic experience.
- Evidence of strong project management skills - preference given to those with PM certification
- Being able to work in situations of ambiguity - bringing clarity and direction to others to achieve goals of the program.
- Highly motivated with a proactive approach to be solution focused.
- Strong written and verbal communication skills.
- Good organizational and time management skills.
- Deep understanding of contract needs (budgets and content) .
If you are having difficulty in applying or if you have any questions, please contact Jacqueline Zafrani at (+1) 213-893-4997 or firstname.lastname@example.org.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.